AssayIndex

AX-2024-004291

TB-500 · 2 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2401-S6494

MARGINALVERIFIED
Report ID
AX-2024-004291
Compound
TB-500
Compound class
Tissue-repair and immunomodulatory peptides
Supplier
QSC — Qingdao Sigma Chemical Co., Ltd.
Batch / lot
QSC-2401-S6494
Declared label claim
2mg
Laboratory
Janoshik Analytical
Assay date
26 Feb 2024
Submitted
10 Mar 2024
Quarter
2024-Q1
Submitter
n.ekstrom
Sample provenance
Buyer-sourced
Section 1

Results

Measured against the index acceptance specification for the tissue-repair and immunomodulatory peptides class. A specification is a decision the index made; a result is a measurement. See where each threshold came from.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 30 min gradient, 214 nm99.76% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.24% area≤ 1.5PASS
Largest single impurityRP-HPLC — des-Gln truncate (−128 Da)0.15% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula887.4964Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)887.4954Da—NOT TESTED
Mass accuracyobserved vs theoretical-1.1ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance86.05%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity85.84%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen2.39mg2 mg declaredNOT TESTED
Recovered target peptidegross fill × target content2.052mg2 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim102.6%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate7.17%≤ 10.0PASS
Counter-ion (acetate)anion-exchange ion chromatography6.32%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.46%—NOT TESTED
Endotoxinnot ordered on this submissionnot determined—≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determined—no growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite cake, partial shrinkage from vial wall—white to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.87—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient7.82min7.86 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.15—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²67,672—≥ 20,000PASS
Resolution to nearest impurityvs [D-Thr]-diastereomer0.89—no index criterionREPORTED
Section 2

Chromatogram and peak integration

The figure is drawn from the table. It is not an independent illustration — if a number in the table changed, the trace would change with it.

0357371471072014294 TB-5007.82 min · 99.76 % 7.58 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 30 min gradient, 214 nm. Drawn from the peak-integration table below: peak positions are the reported retention times, peak areas are the reported area percentages, peak widths follow the reported plate count of 67,672, and skew follows the reported asymmetry factor of 1.15. Baseline noise is seeded from the report ID and is illustrative. The lower panel is the same trace at a stated vertical expansion with the slow gradient drift subtracted, because at full scale a 0.15 % impurity against a 99.76 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1TB-500 — main peak7.824,848,64599.76—
2des-Gln truncate (−128 Da)7.587,2900.15-128.059
3[D-Thr]-diastereomer7.712,4300.050.000
4des-acetyl TB-500 (−42 Da)7.301,9440.04-42.011
Closure check — purity + Σ impurities 100.00CLOSES

Reporting threshold 0.05 % area. Peaks below it are not reported and are therefore excluded from the total, which overstates purity by their sum — see peak integration.

Section 3

Mass spectrum and identity

Theoretical monoisotopic mass 887.4964 Da, computed from C39H69N9O14. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100375475575675775875975 [M+1H]1+888.50[M+2H]2+444.75 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 887.4954 Da. Sodium (+21.982/z) and potassium (+37.956/z) adducts are shown where the parent charge state exceeds 25 % relative abundance; they are adducts of the same molecule and are not impurities.
ChargeTheoretical m/zObserved m/zΔ m/zRel. abundance (%)
2+444.7555444.7550-0.000557.9
1+888.5037888.5027-0.0010100.0
Section 4

Gravimetric mass balance

Water, counter-ion, residual and total peptide content are exhaustive and mutually exclusive categories. They must account for 100 % of the cake mass. The index closes this to within 0.02 pp and the build asserts it.

ComponentDetermination%w/w of cake
WaterKarl Fischer7.17
Counter-ion (acetate)ion chromatography6.32
Residual solvent + inorganic residueestimated0.46
Total peptide contentby difference86.05
Total100.00 CLOSES

Supplier certificate, as declared

The supplier's own figures for this lot, beside the independent measurement. Divergence is assessed against the batch median, not against this single report — see rule AX-R05.

FigureSupplier COAThis reportIndex note
Purity (% area)100.599.76divergence +0.58 pp vs batch median
Total impurities (% area)-0.500.24
Largest single impurity (% area)not stated0.15
Water (%)5.37.17
Counter-ion (%)not stated6.32
Peptide content (%w/w)89.986.05
Endotoxin (EU/mg)not statednot determined
Method stated on certificateYES—column, gradient and wavelength given
Section 5

Provenance and caveats

Where a sample came from changes the weight of the evidence. The index treats it as a first-class field.

Sample provenance
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Retail purchase → submitter (ambient, 27 d) → laboratory (courier, cold pack, 6 d) → assay.
Assay date
26 Feb 2024
Submitted to the index
10 Mar 2024
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
Section 6

Annotations 3

Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.

sig_figs
Two decimal places on 99.76 % implies repeatability better than 0.01 pp, which no laboratory here claims. The number is sound; the printed precision is more than the method carries.
Index data team

Two decimal places are retained because the source reports carry them and truncating would discard information where a laboratory genuinely reports it. The uncertainty budget on /methods/uncertainty-budget/ is the right thing to read alongside any purity figure on this site.

c18_2p6
Column chemistry flatters or punishes a figure like this. A core-shell column at this gradient resolves the close-eluting family that a fully porous 5 µm bed merges, so 99.76 % here is a harder number than the same figure from a coarser column.
survodutide_mixup
Where two compounds elute within a third of a minute, a mass at this accuracy is what separates them. Retention alone would not have.
Section 7

Related records

Same batch — lot QSC-2401-S6494 n=8

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-004284QSC-2401-S6494PeptideMeter2024-Q199.936.38—Buyer-sourced1MARGINAL
AX-2024-004285QSC-2401-S6494Medutest2024-Q199.936.53107.0Buyer-sourced2FAIL
AX-2024-004286QSC-2401-S6494PeptideMeter2024-Q199.836.17101.9Buyer-sourced1MARGINAL
AX-2024-004287QSC-2401-S6494PeptideMeter2024-Q199.937.2689.7Buyer-sourced2MARGINAL
AX-2024-004288QSC-2401-S6494Janoshik2024-Q199.916.42—Buyer-sourced1MARGINAL
AX-2024-004289QSC-2401-S6494Medutest2024-Q199.937.13—Buyer-sourced1MARGINAL
AX-2024-004290QSC-2401-S6494Janoshik2024-Q199.706.1193.6Buyer-sourced1MARGINAL

Cross-sections

Other recent TB-500 records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041776ASYASY-{CAT}-2167Janoshik2026-Q399.924.6198.2Buyer-sourced0PASS
AX-2026-041777ASYASY-{CAT}-2167PeptideMeter2026-Q399.784.0992.8Buyer-sourced0PASS
AX-2026-041782ASYASY-{CAT}-2167Nordanalyt2026-Q399.933.94—Buyer-sourced0PASS
AX-2026-041774ASYASY-{CAT}-2167PeptideMeter2026-Q399.934.4196.2Buyer-sourced0PASS
AX-2026-042127JEEPJEEP-2602-V8614Medutest2026-Q399.683.55—Buyer-sourced1FAIL
AX-2026-042021AMBAMB-2602-P5987VendorInvestigate2026-Q399.864.79101.4Buyer-sourced0PASS
AX-2026-041780ASYASY-{CAT}-2167Janoshik2026-Q399.933.48102.5Buyer-sourced1FAIL
AX-2026-041779ASYASY-{CAT}-2167Janoshik2026-Q399.843.85—Buyer-sourced1FAIL
Other recent QSC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041599CJC-1295 (no DAC)QSC-2606-V7416VendorInvestigate2026-Q397.963.52—Buyer-sourced1FAIL
AX-2026-041601CJC-1295 (no DAC)QSC-2606-V7416Kestrel2026-Q398.334.10—Buyer-sourced1MARGINAL
AX-2026-041602CJC-1295 (no DAC)QSC-2606-V7416VendorInvestigate2026-Q398.363.38101.8Buyer-sourced1MARGINAL
AX-2026-041477TriptorelinQSC-2607-C5749Nordanalyt2026-Q399.533.42—Buyer-sourced0PASS
AX-2026-041600CJC-1295 (no DAC)QSC-2606-V7416Nordanalyt2026-Q397.744.91100.9Buyer-sourced1FAIL
AX-2026-041603CJC-1295 (no DAC)QSC-2606-V7416PeptideMeter2026-Q398.434.20—Buyer-sourced1MARGINAL
AX-2026-041606CJC-1295 (no DAC)QSC-2606-V7416Janoshik2026-Q398.033.58—Buyer-sourced1MARGINAL
AX-2026-041585LiraglutideQSC-2605-W7381Medutest2026-Q399.595.0992.8Laboratory-retained0PASS